1. Field of the Invention
This invention relates to systems to perform arthroscopies of joints such as the knee and more particularly relates to a diagnostic needle arthroscopy and lavage, (DNAL) system for performing arthroscopies through a single port.
2. Background Information
Arthroscopy is a surgical procedure in which an endoscope (arthroscope) is inserted into a joint. Fluid is then injected into the joint to slightly distend the joint and allow visualization of structures within the joint. Surgery is usually viewed on a monitor so that the whole operating team can visualize the surgical procedure that is being performed. The arthroscopy procedure falls into two types; operative and diagnostic. Operative arthroscopy is more interventional, utilizing larger devices and multiple ports to accomplish a variety of procedures designed to repair internal derangement or tears of intra-articular structures. Diagnostic arthroscopy is less invasive, requiring smaller devices and a single port of entry into the joint. Operative arthroscopes are typically four (4) mm in diameter. The operative arthroscopic procedure is often conducted under general anesthesia and is used to examine and treat the inside of the joint for damaged tissue. Most common types of surgery using operative arthroscopic procedures includes the removal or repair of torn meniscus (cartilage), ligament reconstruction, removal of loose debris and trimming or shaving damaged cartilage. Diagnostic arthroscopy is done under local anesthetic only and is most often accompanied by a thorough rinsing out of the joint (lavage).
The value of arthroscopy as a diagnostic and-therapeutic tool is well recognized by physicians. Recent advances have made it technically feasible to perform diagnostic needle arthroscopy procedures in a physician""s office using a small, 1.7 mm fiberoptic arthroscope. Generally the diagnostic needle arthroscopy and lavage procedure is used to diagnose and evaluate joint pathology and relieve pain and limited range of motion symptoms from ostheoarthritis that is not relieved by traditional, conservative medical treatment and management. It is also utilized in treating refractory synovitis and determining uncertain etiology. The DNAL procedure has also been found to be an excellent alternative for those patients unable to tolerate the risks of general anesthesia or are unwilling/unable to undergo joint replacement.
Osteoarthritis is a common problem for many middle-aged and elderly people. Osteoarthritis is sometimes referred to as degenerative, or wear-and-tear arthritis, produced by aging. It can also result from a direct injury to the joint. Instability from ligament damage and/or meniscal injuries cause abnormal wear and tear of he cartilage on the knee joint. Not all cases of ostheoarthritis are related to prior injury however. Research has shown that many are prone to develop osteoarthritis and the tendency may be genetic. Obesity is also a contributory factor. The main problem of osteoarthritis is degeneration of the cartilage that covers articulating surfaces of the joint, resulting in areas of the joint where bone rubs against bone creating bone spurs. Generally osteoarthritis develops slowly over several years. The symptoms are mainly pain, swelling, and stiffening of the joint. As the condition worsens or progresses, pain can interfere with simple, daily activities. Traditional conservative methods of medical treatment include taking anti-inflammatory medication and cortisone injections to reduce the swelling and inflammation of the joint and a variety of pain medications to suppress the bodies pain response. Recently, intra-articular injections of hyaluronic acid, a natural substance found in synovial fluid, has been added to the physician""s arsenal in fighting the debilitating effects of OA.
Recently arthroscopic surgeries have been performed in the doctor""s office to diagnose and treat a variety of symptoms including osteoarthritis, rheumatoid arthritis, crystal-induced arthritis, and pain of unknown etiology. DNAL performed in the physician""s office is done under local anesthetic, with the patient awake throughout the procedure. A video monitor is typically used and the patient may observe the procedure if desired. The surgical site is prepared and draped in the appropriate manner and the procedure is performed under sterile conditions. Local anesthesia is injected into the tissue surrounding the surgical site and also into the joint.
The correct placement of an entry port or portal is performed in the usual fashion using the cannula with a sharp trocar inserted to pierce the surface tissue and then a blunt trocar (obturator) to pop through the joint capsule. The blunt obturator is removed from the cannula and the 1.7 mm arthroscope is inserted in its place. Irrigation is performed through the cannula which is connected by tubing to a hanging bag of irrigation solution (sterile saline) under pressure. Infusion of saline is performed until a clear visual field is obtained and is intermittently maintained throughout the procedure.
With the arthroscope inserted in the cannula and a clear field, the compartments of the knee may be visualized and inspected. If biopsy of interarticular tissue is desired or cartilage thickness and quality needs to be evaluated, a biopsy cannula is used to replace the diagnostic cannula and the appropriate instrument used. This is accomplished through the same single port into the joint and under visualization.
The irrigation or lavage of the joint and subsequent aspiration or removal of fluid, removes particulate matter and loose bodies floating in the joint and has been clinically documented in having beneficial effects with regard to pain relief. The flushing of diseased synovial fluid containing irritants, a byproduct of OA, is also therapeutic. By comparison, operative arthroscopy requires a minimum of two larger ports into the joint for biopsy; one for the arthroscope and one for instrumentation. A disadvantage of the present system of operative arthroscopy is the requirement for a second portal for insertion of surgical instruments.
It is therefore one object of the present invention to provide a diagnostic needle arthroscopy and lavage system using a single port entry system allowing the physician to use a minimally invasive, direct visualization approach for diagnosis and also provide therapeutic benefit of complete flushing of the joint with sterile saline (lavage).
Another object of the present invention is to provide a unique proprietary suction/irrigation handpiece that doubles as a diagnostic entry cannula into the joint and also as a housing for a 1.7 mm fiberoptic arthroscope during the procedure. The handpiece also provides suction and irrigation capabilities on demand through finger controlled trumpet valves.
Another object of the present invention is to provide a diagnostic needle arthroscopy and lavage system that permits diagnostic evaluation of a joint along with therapeutic lavage which provides long-term pain reduction/relief by flushing loose bodies and the chemical irritants commonly found in chronic osteoarthritis (OA) and rheumatoid arthritis (RA).
Yet another object of the present invention is to provide a diagnostic needle arthroscopy and lavage system that uses devices of very small size and a single entry port that is an advantage over multiple punctures and larger ports used in standard operative arthroscopy making the procedure ideal for use in a physician""s office. With the system disclosed and described, arthroscopic diagnosis and lavage may be performed under local anesthetic only and in conjunction with a mild oral sedative. Patients experience minimum discomfort and generally return to normal activities the next day.
Still another object of the present invention is to provide a diagnostic needle arthroscopy and lavage system as an alternative to magnetic resonance imaging (MRI) for diagnosing joint disease and derangement. The diagnostic needle arthroscopy and lavage procedure is both diagnostic and therapeutic while the MRI is only diagnostic and does not permit the opportunity to visualize joint pathology directly, sample tissue, or allow certain interventional treatment modalities.
Direct visualization of joint surfaces and pathology is a superior form of diagnosis when compared to MRI and is also another object of the invention.
Still another object of the present invention is to provide a diagnostic needle arthroscopy and lavage procedure that allows some patients, particularly the elderly, those with heart disease, compromised respiratory function and diabetics, that are not candidates for traditional operative procedures that have the added risk of general anesthesia, to be treated. The system of the present invention provides those patients who have failed conservative medical management and are unable to undergo total or partial joint replacement, a minimally invasive alternative with a high rate of clinically documented success.
The purpose of the present invention is to provide a diagnostic needle arthroscopy and lavage system that permits examination and treatment through a single port entry allowing a physician to use minimally invasive, direct visualization approach for diagnosis.
Suction and irrigation have been standard features in operative arthroscopy (joint), laparoscopy (abdomen/pelvis), cystoscopy (bladder), and hysteroscopy (uterus) for several years. Laparoscopy and hysteroscopy currently use carbon dioxide (CO2) gas as the primary distention media which is electrically monitored and controlled. Hysteroscopy also uses fluid as the distention media, similar to operative arthroscopy and cystoscopy. Operative arthroscopy, hysteroscopy, and cystoscopy primarily use irrigation fluid as distention media only, allowing the specific cavity or organ to be extended or open for viewing and performing operative tasks.
The suction and irrigation aspect in laparoscopy uses fluids in a lavage fashion for flushing the cavity/tissue/organ of blood and debris for better visualization, but the distension of the abdomen is accomplished with CO2 gas. Both arthroscopy and laparoscopy require a sharp puncture through tissue to enter the respective cavity while in hysteroscopy, the entry into the uterus is through the vagina and dilation of the cervix and in cystoscopy through dilation of the urethra. No sharp instruments are used in either for the purpose of cavity entry.
Operative arthroscopy generally has irrigation entering through one port and suction through a second port or through the shaving device introduced through a second port. Hysteroscopy and cystoscopy utilize an outer sheath around the scope which allows the constant inflow and outflow of fluid, preset at specific volume and flow levels and controlled by machine. When fluid is the primary distention media in hysteroscopy, flow can also be controlled intermittently with the use of a physician operated foot pedal.
The diagnostic needle arthroscopy and lavage system of the present invention is distinguished from the usual system and method described above because both inflow and outflow are intermittent and totally physician controlled by trumpet valve buttons on a handpiece. In laparoscopy the inflow and outflow are intermittently controlled via trumpet valve buttons similar to the system disclosed herein, but the suction/irrigation is accomplished through a separate suction/irrigation device introduced through a second port. The device disclosed herein is a suction/irrigation device that combines separate button valves, physician controlled for both suction and irrigation, and doubling as an entry cannula. It is also the only suction/irrigation device that doubles as the scope cannula and permits a single puncture only.
The diagnostic needle arthroscopy and lavage system is particularly adaptable to performing office-based procedures. The single port entry system allows the physician to use minimally invasive direct visualization for diagnosis and also provide therapeutic benefit by completely flushing the joint with sterile saline (lavage). The single port entry is facilitated through a unique disposable suction/irrigation handpiece which doubles as diagnostic entry cannula into the joint and also as the housing for the small fiberoptic arthroscope during the procedure. Separate irrigation and suction capabilities are incorporated in the handpiece and are physician accessed on demand through finger-controlled trumpet valves.
The disposable handpiece""s integral suction and irrigation tubing set connects the handpiece to the respective dual canister vacuum pump and dual irrigation pump which is pressure controlled via a separate air compressor. These components are mounted on a portable procedure cart which also contains a video system housing the camera, light source, lensing and focus in a single enclosure. The video system also includes a high-resolution monitor for viewing and a video recording or video printing device for documenting the procedure.
Additional capabilities for biopsy under visualization through the single port are accomplished with a separate, unique biopsy cannula which is exchanged with the diagnostic cannula via an exchange rod. The scope is removed from the handpiece and the exchange rod inserted in its place. The diagnostic cannula and attached suction/irrigation handpiece may then be removed leaving only the exchange rod in the joint. The diagnostic cannula is then unscrewed from the front of the suction irrigation handpiece and the larger diameter biopsy cannula is attached in its place.
Prior to insertion of the biopsy cannula, the tapered dilator shaft is slipped over the exchange rod and inserted into the joint, gently expanding the portal opening to accommodate the larger sized cannula. The tapered dilator shaft is removed and the biopsy cannula and attached suction/irrigation handpiece are then slipped back over the exchange rod and inserted into the joint, eliminating the time-consuming nuisance of finding the original entry path into the joint. The exchange rod may then be removed and replaced with the arthroscope. A 1 mm biopsy forceps is then inserted through the auxiliary valve mounted on the biopsy cannula body allowing for biopsy under direct visualization. Additional 1 mm devices for use through the auxiliary valve of the biopsy cannula permit cutting and shaving/ablation of tissue.
The system disclosed is intended as a diagnostic procedure for joint evaluation while therapeutic lavage provides long-term (6-24 months) pain reduction/relief by flushing out loose bodies and chemical irritants commonly found in chronic osteoarthritis (OA) and rheumatoid arthritis (RA). The small size of the devices (less than half the size of standard, operative arthroscope) and single-entry port rather than multiple punctures and ports in standard operative arthroscopy, make this procedure ideal for a physician""s office. The procedure is performed under local anesthetic only and in conjunction with a mild oral sedative (e.g., Valium), eliminating the additional risks and associated complications of general anesthesia or spinal epidural injections. Patients undergoing the procedure experience minimal discomfort and return to normal activities the next day.
At the onset of the procedure a sharp trocar is inserted into the suction/irrigation handpiece and attached diagnostic cannula. The entire device is then inserted into the joint to the level of the joint capsule. The sharp trocar after piercing the surface tissue is replaced with a blunt trocar (obturator) and xe2x80x9cpoppedxe2x80x9d into the interior of the joint through the joint capsule. The blunt trocar is removed and replaced with the fiberoptic arthroscope and after attaching the disposable handpiece""s integral suction/irrigation tubing set to the respective devices located off the sterile field; irrigation and aspiration of the joint with sterile saline commences.
The joint is alternately irrigated and suctioned until a clear picture is obtained, the diagnosis is performed while continuing to flush as needed to maintain a clear operative field and to wash out loose bodies and irritants contained within the joint. Generally 1 to 3 liters of saline are used to perform the lavage and to clean the joint of loose debris. Should a biopsy be desired, the procedure for exchanging diagnostic and biopsy cannula can be used.
The diagnostic and biopsy cannula are attached to a threaded coupling or fixture that includes a stopcock or ball valve that allows for removal of sterile synovial fluid and loose bodies, and also permits direct injection of anesthetic or drugs, into the joint. In addition, the biopsy cannula""s ball valve is also used for insertion and removal of the biopsy instrument. The invention disclosed herein is the only application of an additional valve on the suction/irrigation device which is different from the large number of standard entry trocar/cannula that utilize a valve for distention purposes only.
The system also includes the use of video coupling optics connected to the camera head, and light source in a single unit located off the sterile field. This eliminates the need to have a camera head and cable, optical coupler, light cable and scope all sterilized and assembled on the field. The only video train component in this system disclosed herein needing sterilization is the fiberoptic scope which contains integral illumination fibers. The 1.7 mm scope in this system uses a 30,000 pixel fiber image bundle with a two-element distal lens which provides the image quality, large field of view, and depth of field approaching that of a 4 mm rod lens arthroscope.